510(k) K231870 ยท DQK Computer, Diagnostic, Programmable
CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System
| Applicant | Ge Medical Systems Information Technologies, Inc., Wauwatosa WI, US |
| Decision | Substantially Equivalent, Dec 13, 2023 |
| Received | Jun 26, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231870
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 1, 2026 | GE Medical Systems Information Technologies Inc CASE v7.0 Cardiac Testing System
Model no. 3031234-001
Product Code SU3 Open, Classified |
DQK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.